Trial Outcomes & Findings for Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine (NCT NCT02745392)

Last Updated: 2018-03-13

Results Overview

Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints. Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose. Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

365 participants

Primary outcome timeframe

2 hours

Results posted on

2018-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)	ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 3.8 mg ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Overall Study STARTED	91	90	92	92
Overall Study COMPLETED	91	89	92	92
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)	ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 3.8 mg ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Overall Study Lost to Follow-up	0	1	0	0

Baseline Characteristics

Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=77 Participants Either single or double patch administration	ZP-Zolmitriptan 1 mg n=79 Participants Single 1 mg patch administration	ZP-Zolmitriptan 1.9 mg n=83 Participants Single 1.9 mg patch administration	ZP-Zolmitriptan 3.8 mg n=82 Participants Double 1.9 mg patch administration	Total n=321 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 11.53 • n=93 Participants	41.7 years STANDARD_DEVIATION 11.58 • n=4 Participants	40.1 years STANDARD_DEVIATION 10.92 • n=27 Participants	41.0 years STANDARD_DEVIATION 11.39 • n=483 Participants	41.3 years STANDARD_DEVIATION 11.34 • n=36 Participants
Sex: Female, Male Female	69 Participants n=93 Participants	70 Participants n=4 Participants	73 Participants n=27 Participants	68 Participants n=483 Participants	280 Participants n=36 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	9 Participants n=4 Participants	10 Participants n=27 Participants	14 Participants n=483 Participants	41 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants	13 Participants n=4 Participants	14 Participants n=27 Participants	15 Participants n=483 Participants	53 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=93 Participants	66 Participants n=4 Participants	69 Participants n=27 Participants	67 Participants n=483 Participants	268 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	10 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Black or African American	15 Participants n=93 Participants	16 Participants n=4 Participants	20 Participants n=27 Participants	10 Participants n=483 Participants	61 Participants n=36 Participants
Race (NIH/OMB) White	59 Participants n=93 Participants	58 Participants n=4 Participants	54 Participants n=27 Participants	67 Participants n=483 Participants	238 Participants n=36 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: mITT population includes all subjects who were randomized, received any amount of study drug (applied the patch(es) to treat a qualifying migraine, and had at least 1 post-treatment efficacy assessment

Outcome measures

Outcome measures
Measure	Placebo n=77 Participants Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)	ZP-Zolmitriptan 1 mg n=79 Participants ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 1.9 mg n=83 Participants ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 3.8 mg n=82 Participants ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Proportion of Subjects With Pain Freedom	11 Participants	24 Participants	23 Participants	34 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: mITT

The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.

Outcome measures

Outcome measures
Measure	Placebo n=77 Participants Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)	ZP-Zolmitriptan 1 mg n=79 Participants ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 1.9 mg n=83 Participants ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 3.8 mg n=82 Participants ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)	33 Participants	45 Participants	44 Participants	56 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

ZP-Zolmitriptan 1 mg

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

ZP-Zolmitriptan 1.9 mg

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

ZP-Zolmitriptan 3.8 mg

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=83 participants at risk Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)	ZP-Zolmitriptan 1 mg n=80 participants at risk ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 1.9 mg n=87 participants at risk ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system	ZP-Zolmitriptan 3.8 mg n=83 participants at risk ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
General disorders Application site erythema	14.5% 12/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	28.7% 23/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	35.6% 31/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	45.8% 38/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
General disorders Application site bruise	3.6% 3/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	6.2% 5/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	13.8% 12/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	14.5% 12/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
General disorders Application site pain	1.2% 1/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.5% 2/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.3% 2/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	9.6% 8/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
General disorders Application site haemorrhage	0.00% 0/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	3.8% 3/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	5.7% 5/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	4.8% 4/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
General disorders Application site swelling	3.6% 3/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.2% 1/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	3.4% 3/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.4% 2/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
General disorders Application site oedema	0.00% 0/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.2% 1/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	3.4% 3/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.4% 2/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
Nervous system disorders Dizziness	0.00% 0/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.2% 1/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	0.00% 0/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	4.8% 4/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
Nervous system disorders Paraesthesia	1.2% 1/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	0.00% 0/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	0.00% 0/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.4% 2/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	0.00% 0/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.1% 1/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.4% 2/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
Gastrointestinal disorders Nausea	0.00% 0/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	2.5% 2/80 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.1% 1/87 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.	1.2% 1/83 • 2-8 days post-study drug administration for a single migraine The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.

Additional Information

Dr. Donald Kellerman

Zosano Pharma Corporation

Phone: (510) 745-4004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60